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A Study of Dalteparin Prophylaxis in High-Risk Ambulatory Cancer Patients (PHACS)

This study has been terminated.
(slow enrollment and lack of continuing funds)
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Eisai Inc.
Information provided by (Responsible Party):
Charles Francis, University of Rochester
ClinicalTrials.gov Identifier:
NCT00876915
First received: March 31, 2009
Last updated: October 28, 2015
Last verified: October 2015
Results First Received: July 24, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: Venous Thromboembolism
Pulmonary Embolism
Intervention: Drug: dalteparin injection

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants screened for the study but deemed low or medium risk by Khorona scoring will be offered to consent to a one time baseline blood sample. These samples will be used as the control group to establish the value of TF as a predictive marker for VTE in ambulatory cancer patients as described in the Secondary Objectives.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Participants who undergo a baseline US/CT scan and are found to have a DVT/PE will be considered a screen failure and will not be randomized and continue on in the study. In addition, if any of the screening criteria are not met, these subjects will be considered screen failures.

Reporting Groups
  Description
High Risk Dalteparin Injection

Patients will be assigned at random to receive prophylactic dalteparin injections

dalteparin injection: Potency is described in international anti-Xa units (IU). One unit (anti-Xa) of dalteparin sodium, average molecular weight 5,000, corresponds to the activity of one unit of the 1st International Standard for Low Molecular Weight Heparin (LMWH)with respect to inhibition of coagulation Factor Xa in plasma utilizing the chromogenic peptide substrate S-2765 (N-alpha-Benzyloxycarbonyl-D-arginyl-glycyl-arginine-pNA.2HCl).

High Risk No Therapy No prophylactic therapy for VTE prevention given (Subjects just receiving standard of care)
Low or Medium Risk Group Subjects deemed low or medium risk for VTE by Khorona score. These subjects did not enter into the study but supplied a one-time baseline blood sample for use as a control in the studies Secondary Objective of establishing the value of TF as a predictive marker for VTE.

Participant Flow:   Overall Study
    High Risk Dalteparin Injection   High Risk No Therapy   Low or Medium Risk Group
STARTED   50   48   101 
Week 4   38   45   0 
Week 8   33   36   0 
COMPLETED   31   34   101 
NOT COMPLETED   19   14   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
High Risk Randomized to Dalteparin Injection

Patients will be assigned at random to receive prophylactic dalteparin injections

dalteparin injection: Potency is described in international anti-Xa units (IU). One unit (anti-Xa) of dalteparin sodium, average molecular weight 5,000, corresponds to the activity of one unit of the 1st International Standard for Low Molecular Weight Heparin (LMWH)with respect to inhibition of coagulation Factor Xa in plasma utilizing the chromogenic peptide substrate S-2765 (N-alpha-Benzyloxycarbonyl-D-arginyl-glycyl-arginine-pNA.2HCl).

High Risk Randomized to No Therapy No prophylactic therapy for VTE prevention given (Subjects just receiving standard of care)
Low Risk Ambulatory cancer patients deemed Low risk based on a Khorona score of 0-2
Total Total of all reporting groups

Baseline Measures
   High Risk Randomized to Dalteparin Injection   High Risk Randomized to No Therapy   Low Risk   Total 
Overall Participants Analyzed 
[Units: Participants]
 50   48   101   199 
Age 
[Units: Participants]
       
<=18 years   0   0   0   0 
Between 18 and 65 years   34   35   74   143 
>=65 years   16   13   27   56 
Age 
[Units: Years]
Mean (Standard Deviation)
 60  (10)   58  (12)   58  (13)   58  (12) 
Gender 
[Units: Participants]
       
Female   21   24   41   86 
Male   29   24   60   113 
Ethnicity (NIH/OMB) 
[Units: Participants]
       
Hispanic or Latino   2   3   1   6 
Not Hispanic or Latino   48   45   96   189 
Unknown or Not Reported   0   0   4   4 
Race (NIH/OMB) 
[Units: Participants]
       
American Indian or Alaska Native   2   2   0   4 
Asian   2   0   1   3 
Native Hawaiian or Other Pacific Islander   1   1   0   2 
Black or African American   7   8   9   24 
White   38   37   91   166 
More than one race   0   0   0   0 
Unknown or Not Reported   0   0   0   0 
Region of Enrollment 
[Units: Participants]
       
Canada   4   3   0   7 
United States   46   45   101   192 


  Outcome Measures
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1.  Primary:   Percentage of Patients With Venous Thromboembolisms   [ Time Frame: 12 weeks ]

2.  Primary:   Percentage of Patients Who Experienced Clinically Significant Bleeding Events.   [ Time Frame: 13 weeks ]

3.  Secondary:   The Value of Tissue Factor (TF) at Baseline Prior to Chemotherapy in Ambulatory Cancer Patients   [ Time Frame: baseline value of tissue factor ]

4.  Secondary:   The Value of D-Dimer at Baseline Prior to Chemotherapy in Ambulatory Cancer Patients   [ Time Frame: baseline value of D-Dimer ]

5.  Secondary:   The Value of Human F12 at Baseline Prior to Chemotherapy in Ambulatory Cancer Patients   [ Time Frame: baseline value of Human F12 ]

6.  Secondary:   The Value of Tissue Factor Pathway Inhibitor (TFPI) at Baseline Prior to Chemotherapy in Ambulatory Cancer Patients   [ Time Frame: baseline value of TFPI ]

7.  Secondary:   The Value of Factor VIIa (FVIIa) at Baseline Prior to Chemotherapy in Ambulatory Cancer Patients   [ Time Frame: baseline value of FVIIa ]

8.  Secondary:   The Value of Thrombin Antithrombin (TAT) at Baseline Prior to Chemotherapy in Ambulatory Cancer Patients   [ Time Frame: baseline value of TAT ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Charles Francis, MD
Organization: University of Rochester
phone: (585) 275-5823
e-mail: charles_francis@urmc.rochester.edu



Responsible Party: Charles Francis, University of Rochester
ClinicalTrials.gov Identifier: NCT00876915     History of Changes
Other Study ID Numbers: 25387
1R01HL095109-01 ( US NIH Grant/Contract Award Number )
Study First Received: March 31, 2009
Results First Received: July 24, 2015
Last Updated: October 28, 2015
Health Authority: United States: Institutional Review Board